CAPA Specialist - Processing

Sturgis, Michigan, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, NutritionIndustries

Requirements

Candidates should possess a Bachelor’s degree in a related field, and demonstrate at least 3 years of experience in CAPA systems, with a strong understanding of quality systems and regulatory requirements. Experience with investigation tools and data analysis is preferred.

Responsibilities

The CAPA Specialist will progress investigations through the CAPA system, working with other functional areas to determine root causes and ensure effective CAPA plans are implemented. They will evaluate the timely completion of CAPA activities, facilitate investigations, maintain system records, and support a team environment while ensuring compliance with corporate and regulatory requirements. The role involves supporting the attainment of division goals and objectives, and ensuring the CAPA system is effectively managed for audit readiness and regulator compliance.

Skills

CAPA system

investigational tools

root cause analysis

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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